Daniel O Clark1, Huiping Xu2, Lyndsi Moser3, Philip Adeoye4, Annie W Lin5, Christy C Tangney6, Shannon L Risacher7, Andrew J Saykin7, Robert V Considine8, Frederick W Unverzagt9. 1. Indiana University Center for Aging Research, Indianapolis, IN, United States of America; Regenstrief Institute, Inc., Indianapolis, IN, United States of America; Department of Medicine, Division of General Internal Medicine and Geriatrics, Indiana University School of Medicine, Indianapolis, IN, United States of America. Electronic address: daniclar@iu.edu. 2. Indiana University Center for Aging Research, Indianapolis, IN, United States of America; Regenstrief Institute, Inc., Indianapolis, IN, United States of America; Indiana University Richard M. Fairbanks School of Public Health, Indianapolis, IN, United States of America. 3. Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, United States of America. 4. Indiana University Center for Aging Research, Indianapolis, IN, United States of America; Regenstrief Institute, Inc., Indianapolis, IN, United States of America. 5. Department of Preventive Medicine, Northwestern University, Chicago, IL, United States of America. 6. Department of Clinical Nutrition, Rush University Medical Center, Chicago, IL, United States of America. 7. Center for Neuroimaging, Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN, United States of America. 8. Department of Medicine, Division of Endocrinology, Indiana University School of Medicine, Indianapolis, IN, United States of America. 9. Indiana University Center for Aging Research, Indianapolis, IN, United States of America; Regenstrief Institute, Inc., Indianapolis, IN, United States of America; Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, United States of America.
Abstract
BACKGROUND: Multiple national organizations and leaders have called for increased attention to dementia prevention in those most vulnerable, for example persons with limited formal education. Prevention recommendations have included calls for multicomponent interventions that have the potential to improve both underlying neurobiological health and the ability to function despite neurobiological pathology, or what has been termed cognitive reserve. OBJECTIVES: Test feasibility, treatment modifier, mechanism, and cognitive function effects of a multicomponent intervention consisting of foods high in polyphenols (i.e., MIND foods) to target neurobiological health, and speed of processing training to enhance cognitive reserve. We refer to this multicomponent intervention as MINDSpeed. DESIGN: MINDSpeed is being evaluated in a 2 × 2 randomized factorial design with 180 participants residing independently in a large Midwestern city. Qualifying participants are 60 years of age or older with no evidence of dementia, and who have completed 12 years or less of education. All participants receive a study-issued iPad to access the custom study application that enables participants, depending on randomization, to select either control or MIND food, and to play online cognitive games, either speed of processing or control games. METHODS: All participants complete informed consent and baseline assessment, including urine and blood samples. Additionally, up to 90 participants will complete neuroimaging. Assessments are repeated immediately following 12 weeks of active intervention, and at 24 weeks post-randomization. The primary outcome is an executive cognitive composite score. Secondary outcomes include oxidative stress, pro-inflammatory cytokines, and neuroimaging-captured structural and functional metrics of the hippocampus and cortical brain regions. SUMMARY: MINDSpeed is the first study to evaluate the multicomponent intervention of high polyphenol intake and speed of processing training. It is also one of the first dementia prevention trials to target older adults with low education. The results of the study will guide future dementia prevention efforts and trials in high risk populations.
RCT Entities:
BACKGROUND: Multiple national organizations and leaders have called for increased attention to dementia prevention in those most vulnerable, for example persons with limited formal education. Prevention recommendations have included calls for multicomponent interventions that have the potential to improve both underlying neurobiological health and the ability to function despite neurobiological pathology, or what has been termed cognitive reserve. OBJECTIVES: Test feasibility, treatment modifier, mechanism, and cognitive function effects of a multicomponent intervention consisting of foods high in polyphenols (i.e., MIND foods) to target neurobiological health, and speed of processing training to enhance cognitive reserve. We refer to this multicomponent intervention as MINDSpeed. DESIGN: MINDSpeed is being evaluated in a 2 × 2 randomized factorial design with 180 participants residing independently in a large Midwestern city. Qualifying participants are 60 years of age or older with no evidence of dementia, and who have completed 12 years or less of education. All participants receive a study-issued iPad to access the custom study application that enables participants, depending on randomization, to select either control or MIND food, and to play online cognitive games, either speed of processing or control games. METHODS: All participants complete informed consent and baseline assessment, including urine and blood samples. Additionally, up to 90 participants will complete neuroimaging. Assessments are repeated immediately following 12 weeks of active intervention, and at 24 weeks post-randomization. The primary outcome is an executive cognitive composite score. Secondary outcomes include oxidative stress, pro-inflammatory cytokines, and neuroimaging-captured structural and functional metrics of the hippocampus and cortical brain regions. SUMMARY: MINDSpeed is the first study to evaluate the multicomponent intervention of high polyphenol intake and speed of processing training. It is also one of the first dementia prevention trials to target older adults with low education. The results of the study will guide future dementia prevention efforts and trials in high risk populations.
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